EU-IN_VITRO_MEDICAL_DEVICES-ART_3_ANX_1

In Vitro Diagnostic Medical Devices Directive - Hazardous Substances

EU. Hazardous Substances for Purposes of Article 3 & Annex I (Essential Requirements), Directive 98/79/EC on In Vitro Diagnostic Medical Devices, 7 December 1998

This list contains a non-exhaustive inventory of hazardous substances for purposes of essential requirements (Article 3 and Annex I) for general safety, design, manufacture and hazard communication of in vitro diagnostic medical devices. It is derived from: Table 3 of Annex VI to CLP, REACH Candidate List of SVHCs, and Directive 2000/54/EC's Annex III (Biological Agents list). Note that Regulation 2017/746/EU on in vitro diagnostic medical devices was published in the EU Official Journal on 5 May 2017. With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.

Last updated 26 April 2024. Database contains 4821 unique substances/entries.
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205-500-4
141-78-6
Flam. Liq. 2; Eye Irrit. 2; STOT SE 3
205-438-8
140-88-5
Flam. Liq. 2; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
203-290-9
105-36-2
Acute Tox. 2; Acute Tox. 1
203-294-0
105-39-5
Acute Tox. 3
203-721-0
109-94-4
Flam. Liq. 2; Acute Tox. 4; Eye Irrit. 2; STOT SE 3
203-722-6
109-95-5
Flam. Gas 1; Press. Gas; Acute Tox. 4
203-291-4
105-37-3
Flam. Liq. 2
EAPOXC
421-790-7
13014-29-4
Water-react. 1; Skin Corr. 1A
BETA-DAASE; BETA-DIMETHYLAMIMO ACRYLIC ACID ETHYLESTER
402-650-4
1117-37-9
Skin Sens. 1
202-849-4
100-41-4
Flam. Liq. 2; Acute Tox. 4; STOT RE 2; Asp. Tox. 1
203-468-6
107-15-3
Flam. Liq. 3; Acute Tox. 4; Skin Corr. 1B; Resp. Sens. 1; Skin Sens. 1
yes
Z-2
400-520-1
164907-74-8
Skin Corr. 1B; Acute Tox. 4
205-793-9
151-56-4
Flam. Liq. 2; Carc. 1B; Muta. 1B; Acute Tox. 2; Acute Tox. 1; Skin Corr. 1B
Residue from the distillation of dephenolated and debased methylnaphthalene oil (from bituminous coal tar and pyrolysis residual oils) with a boiling range of 240°C to 260°C (464°F to 500°F). Composed primarily of substituted dinuclear aromatic and heterocyclic hydrocarbons.
310-171-6
122070-80-8
Carc. 1B; Muta. 1B
A neutral oil obtained by debasing and dephenolating the oil obtained from the distillation of high temperature tar and pyrolysis residual oils which has a boiliing range of 225°C to 255°C (437°F to 491°F). Composed primarily of substituted dinuclear aromatic hydrocarbons.
310-170-0
122070-79-5
Carc. 1B; Muta. 1B
A complex combination of hydrocarbons obtained by the redistillation of the distillate of high temperature coal tar (tar acid and tar base free). It consists predominantly of unsubstituted and substituted mononuclear aromatic hydrocarbons boiling in the range of 85°C-195°C (185°F-383°F).
309-868-8
101316-63-6
Carc. 1B; Muta. 1B
A complex combination of hydrocarbons from the base-free fraction from the distillation of coal tar, boiling in the range of approximately 250°C to 280°C (482°F to 536°F). It consists predominantly of biphenyl and isomeric dimethylnaphthalenes.
310-189-4
122384-77-4
Carc. 1B
309-867-2
101316-62-5
Carc. 1B; Muta. 1B
The residue from low temperature coal tar oils after an alkaline wash, such as aqueous sodium hydroxide, to remove crude coal tar acids. Composed primarily of hydrocarbons and aromatic nitrogen bases.
310-191-5
122384-78-5
Carc. 1B; Muta. 1B
A complex combination of hydrocarbons remaining after the removal of naphthalene from alkali-washed naphthalene oil by a crystallization process. It is composed primarily of naphthalene and alkyl naphthalenes.
310-167-4
121620-48-2
Carc. 1B; Muta. 1B
A complex combination of hydrocarbons obtained from the alkali washing of naphthalene oil to remove phenolic compounds (tar acids). It is composed of naphthalene and alkyl naphthalenes.
310-166-9
121620-47-1
Carc. 1B; Muta. 1B
A complex combination of hydrocarbons obtained as a fraction from distillation of an extract recovered by solvent extraction of light paraffinic top petroleum distillate treated with activated charcoal to remove traces of polar constituents and impurities. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C16 through C32.
309-672-2
100684-02-4
Carc. 1B
A complex combination of hydrocarbons obtained as a fraction from distillation of an extract recovered by solvent extraction of light paraffinic top petroleum distillates treated with bleaching earth to remove traces of polar constituents and impurities. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C16 through C32.
309-673-8
100684-03-5
Carc. 1B
A complex combination of hydrocarbons obtained by solvent extraction of light vacuum petroleum gas oils treated with bleaching earth for removal of trace polar constituents and impurities. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C13 through C30.
309-675-9
100684-05-7
Carc. 1B
A complex combination of hydrocarbons obtained by solvent extraction of light vacuum petroleum gas oil treated with activated charcoal for the removal of trace polar constituents and impurities. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C13 through C30.
309-674-3
100684-04-6
Carc. 1B
603-520-1
131807-57-3
STOT RE 2
205-419-4
140-56-7
Acute Tox. 3; Acute Tox. 4
238-134-9
14255-88-0
Acute Tox. 4
MAGISTER* F ACARICIDAL CHEMICAL
410-580-0
120928-09-8
Acute Tox. 3; Acute Tox. 4
236-407-7
13356-08-6
Acute Tox. 2; Eye Irrit. 2; Skin Irrit. 2
204-524-2
122-14-5
Acute Tox. 4
603-792-1
134098-61-6
Acute Tox. 3; Acute Tox. 2; Skin Sens. 1B
204-114-3
115-90-2
Acute Tox. 1; Acute Tox. 2
238-484-2
14484-64-1
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
424-610-5
120068-37-3
Acute Tox. 3; STOT RE 1
605-127-0
158062-67-0
Acute Tox. 4
604-290-5
142459-58-3
Acute Tox. 4; STOT RE 2; Skin Sens. 1
FLUFENOXURON
417-680-3
101463-69-8
Lact.
600-425-7
103361-09-7
Repr. 2
205-631-7
144-49-0
Acute Tox. 2
240-898-3
16872-11-0
Skin Corr. 1B
241-034-8
16961-83-4
Skin Corr. 1B
FLUQUINCONAZOLE
411-960-9
136426-54-5
Acute Tox. 3; STOT RE 1; Acute Tox. 4; Skin Irrit. 2
205-088-6
133-07-3
Carc. 2; Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
239-946-6
15843-02-4
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
203-743-0
110-17-8
Eye Irrit. 2
203-727-3
110-00-9
Flam. Liq. 1; Carc. 1B; Muta. 2; Acute Tox. 4; STOT RE 2; Skin Irrit. 2
yes
215-114-8
1303-00-0
Repr. 1B; Carc. 1B; STOT RE 1
603-804-5
134237-52-8
yes
203-377-1
106-24-1
Skin Sens. 1

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